Definition

The process of evaluating whether a detected signal represents a genuine new safety concern warranting further analysis.

Example

A statistical signal for 'cardiac arrest' is validated by reviewing individual case quality, checking for duplicates, assessing biological plausibility, and comparing with external data sources.

Regulatory source

EU GVP Module IX

Common mistakes

Skipping validation and moving directly to labeling changes, or dismissing signals without adequate evaluation.

Inspector question

Walk me through a recent signal validation. What criteria do you use to determine if a signal is validated?

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